Abstract

Minimising the risk of preventable harm to patients is a National Health Service (NHS) priority in the UK. In the past decade, a patient safety agenda has been established in much secondary care, but is only now migrating to primary care. Information about the epidemiology of error, contributory factors and the scale of preventable harm is limited in comparison to what is known in acute hospitals. We describe how to apply a recently developed trigger tool – a rapid audit method of screening electronic patient records to detect patient harm – as a feasible part of routine primary care practice. We promote the idea that the trigger tool approach will enable care teams and clinicians to refocus their learning and improvement efforts on one of the most serious issues facing the NHS or any modern healthcare system – how to minimise the risks of unintended but avoidable harm to patients.

Keywords

Introduction

In the past decade, increasing attention has been given
to improving patient safety by systematically screening
medical records to detect, measure and learn from
avoidable harm.[1,2] The ‘trigger tool method’ is a recognised
approach that allows trained clinicians to review
patients’ healthcare records in a rapid, structured and focused manner.[3] This method may allow clinical
teams to better focus localised learning needs and
implement intervention strategies, thereby reducing
the risk of further harm to patients in those teams’
settings.[4] Self-directed progress can then be monitored
through serial measurement of preventable harm rates and targeted improvement activity.[5,6] Evidence of
trigger tool use in a range of clinical settings is growing
internationally.[6–11]

In the UK this type of rapid record review is largely
confined to acute hospital wards, normally as a key
element of national patient safety initiatives.[12,13] However,
there is growing interest in attempting to adapt
this process for use in UK primary health care. The
NHS Institute for Improvement and Innovation has
since 2009 provided training to clinicians in England
in using a web-based version of the trigger tool for
‘measuring’ harm in general practices.[14] Prior to this,
in NHS Scotland, a primary care trigger tool was
developed and piloted which demonstrated that this
approach can be successful in screening electronic
patient records to identify episodes of avoidable
harm.[15] The pilot involved reviewing 500 randomly
selected medical records using ten clinical triggers,
and found a harm rate of 9.5% with around 40% of
incidents conservatively estimated to have been preventable.
The trigger tool and its method of application
have since been refined in conjunction with
general practitioners (GPs) and practice nurses in a
small number of NHS Scotland health boards to
ensure that it is professionally acceptable to clinicians
and potentially feasible in practice. It is currently being
utilised as a key component of the Health Foundation
funded Safety and Improvement in Primary Care
collaborative programme in NHS Scotland.[16]

In this paper we introduce the trigger tool concept
and describe a practical and flexible way in which
primary care teams and individual clinicians can
engage with the process. The term ‘trigger tool’ may
be unfamiliar to many, but it is not a new approach to
learning. The underlying principle – essentially an
adaptation of case note review – will be familiar to most clinicians. In this respect, we suggest that the
trigger tool may havemuch greater educational utility
beyond one of its core purposes – measuring harm
rates – by helping primary care teams to identify
learning needs and by facilitating local improvements
in the quality and safety of patient care.

What is a trigger tool?

A trigger tool is a simple checklist pro forma containing
a selected number of clinical ‘triggers’ which a
reviewer seeks to identify when screening electronic
medical records.3 ‘Triggers’ are defined as easily identifiable
flags, occurrences or prompts in patient records
that alert reviewers to potential adverse events
that had previously been undetected. For example, an
international normalised ratio (INR) of 5.0 would be a
‘trigger’ for the reviewer to undertake a more focused
examination of a record for evidence of the patient
suffering some type of related haemorrhage. Box 1 contains a list of previously published core triggers
which may act as a useful starting point in conducting
a rapid search of electronic records for evidence of
undetected harm to patients.[15]

What do we mean by avoidable
harm?

The focus of the trigger tool approach is on detecting
incidents of harm to patients, rather than highlighting
evidence of clinical error. A universal understanding and definition of ‘harm’ currently eludes the safety
and improvement community. For the purposes of
this paper we are content to accept the following
definition of harm: ‘unintended physical injury resulting
from or contributed to by medical care that requires
additional monitoring, treatment or hospitalization,
or that results in death’. A pragmatic interpretation of
this definition can be summarised as anything that
happens as a result of interaction with healthcare services
(environment, workers, treatment) that you would not
want to happen to you or your relatives.[17]

Inevitably, the understanding and interpretation of
this definition will vary, but should not significantly
detract from the practice team’s ultimate purpose of
facilitating local learning and improvement through
application of the trigger tool. It is also important to
stress that not all harm in health care is caused by
clinical error or system failure, just as all errors do not
cause harm.

Training in electronic patient
record screening using the
trigger tool

Given the complexity and uncertainty ofmuch patient
care and the potential sensitivities around the circumstances
leading to episodes of preventable harm, only
clinically qualified individuals should be trained in the
application of the trigger tool. As we will see, however,
administrative staff can perform an important supporting
role.

Clinical reviewers require a basic level of training to
ensure a consistent understanding of the key general
principles underpinning the trigger tool and how it
should be applied in practice. Training should be
straightforward; it normally involves the novice reviewer
sitting down at a computer workstation with a
colleague experienced in the process to discuss the
content of the trigger tool and to practise applying
it with a small selection of ‘live’ electronic patient
records (EPRs). Alternatively, novice reviewers can
work their way through the process by reading about
the trigger tool method and practising on simulated
medical records scenarios. The training process normally
lasts around two hours. Once trained, and
having gained some experience of the trigger tool,
the reviewer should be in a position to then train other
clinical colleagues, thereby building local capability
and capacity. Both NHS Education for Scotland and
the NHS Institute for Innovation and Improvement
provide training support resources.[14,18]

The trigger tool process

The trigger tool process can be simplified into the
three stages which are illustrated in Figure 1. The
process is flexible and can be adapted according to the
measurement, learning and improvement aims of
individual clinicians and primary care teams. The
three stages are described in more detail below.

Figure 1: The trigger tool process

Stage 1 Planning and preparation

What is the aim of the review?

At the outset, the clinician or team should clarify
precisely what is the specific aim of the intended review.
This will help them to decide whether a ‘measurement’
or ‘non-measurement’ approach is appropriate. Table 1 suggests howthe process may be adapted by different
professional groups to support a range of safety,
regulatory and educational purposes. A series of short
examples of how and why the tool may be used is
outlined in Box 2.

Sampling of medical records: size,
method, timeframe and frequency

Practical experience suggests that it is feasible to
review up to 20 records in a two- to three-hour
session, with most records taking less than five minutes.
[15] How many records are reviewed and how
frequently this is undertaken is inextricably linked to
the purpose of the review. For example, if a practice
team wishes to attempt to measure the avoidable harm
rate in patients taking high-risk medications, then
they should be looking at systematically reviewing
random samples of records in this subpopulation
on a periodic, three-month basis. It is thought that
repeating this task over a period of time (e.g. 24months)
will provide the practice with ‘metrics’ on the avoidable
harm rate. The reliability of this process is
arguably open to question and will be discussed in
more detail in a second, linked paper.

This type of measurement approach may seem
desirable, but practice teams should take care that
the scale of detected, preventable harm events does not
exceed their capacity and capability to deal effectively
with them. It should also be noted that medical
records must be selected randomly if the aim is to
establish a ‘reliable rate of preventable harm’. Every
patient record in the population being reviewed should
therefore have an equal chance of being selected. There
are various ways to ensure true randomisation. One
approach is to manually select every nth record in the
relevant patient population. Alternatively, a random
number generator may provide an automated solution.
[19]

At the other end of the spectrum, it is also feasible
for a general practice principal, sessional doctor or
practice nurse to adopt a non-measurement strategy
by applying the trigger tool to a small sample of
medical records as either a one-off or regular educational
task. For example, a GP may wish to review
the last 20 elderly patients (75 years of age and greater)
who consulted with her. In this way, individual learning
needs can be identified and action plans documented
(e.g. to undertake a significant event analysis
or implement immediate improvement), which will
contribute towards professional appraisal, CPD credits
and, ultimately, medical revalidation.

We recommend retrospective review of three consecutive
calendar months in the sample of records and
also that the selected time periods do not overlap with
any other comparable reviews. Reviewers may choose any other number of months to review in each selected
patient record, depending on their specific aims and
resources. Longer review periods will increase the
number of detected harm events (but not necessarily
the harm rate). This relative advantage may be offset
by the requirement of additional resources and the fact
that some harm events may be outdated (and so
potentially less amenable to analysis and improvement).

Clinical triggers: how many and which
ones?

It is anticipated that between eight and 12 triggers
should provide the optimal balance between sensitivity
in detecting levels of preventable harm and feasibility
in terms of having sufficient time and resources to
complete the chosen review task, which will of course come at an opportunity cost. The triggers selected are
clearly dependent on the purpose of the review. For
example, ‘INR >5.0’ would be an appropriate trigger
to select if the aim were to screen for anticoagulantassociated
adverse events, but could be omitted when
aiming to calculate a ‘global harm rate’ or to review the
care of a specific patient population, such as those
taking cytotoxic drugs.

What data should be collected?

Essential data to be collected for each trigger tool
review:

flaim of the review

• population under review

• sample size

• name of reviewer(s).

Essential data to be collected for every patient record
reviewed include:

fla patient unique identifier

• whether a harm event(s) is detected.

Essential data to be collected when harm events are
detected include:

• the number of detected ‘harm events’

• the grade of harm severity

• whether the event was judged to be preventable

• the setting where the harm event originated

fla brief narrative description of the harm incident.

Depending on the review aim it may be necessary to
also extract the following data:

• the number and type of consultations

• the number of triggers found

• the time taken to review each record.

Incidental review findings

In addition to these data, reviewers will often come
across other contextual information in the records
which may be important in shedding light on understanding
why detected harm events occurred. This
type of information – unrelated to the aims of the
review being undertaken – may be uncovered inadvertently
but is of value because it highlights other
learning needs for individual clinicians or the practice
team as a whole. For example, incidental findings may
include: clinical errors, administrative and systems
failures and inadequate record keeping which did not
lead to harm events. This should not distract reviewers
from achieving their main objectives or unnecessarily
slow the process.

Involving administrative staff

Administrative staff can play a key role in providing
important practical support when applying the trigger
tool. For example, it is an expectation that experienced
administrative staff will be able to generate lists of
appropriate electronic patient records; select random
samples of records; pre-screen records to identify those
containing relevant clinical triggers; and enter collected
data into spreadsheets, where applicable. Completion
of these tasks will speed up the process and minimise
workload for clinical reviewers. Thereafter, reviewers
can focus on screening the preselected patient records
with identified triggers to ascertain if there is evidence
of harm.

Similarly, medical and nursing staff can provide
practical support to each other. For example, a practice
nurse will be able to pre-screen records for agreed
clinical triggers and also identify probable harm incidents.
The GP and practice nurse are then able to
jointly discuss and agree detected harm events and
describe harm characteristics.

Stage 2 Systematic review of a
random sample of records

Every record in the random sample is reviewed consecutively.
A maximum of 20 minutes review time
should be allowed for each record. Reviewers should
move on to the next record if they are unable to collect
relevant data and make the necessary judgements from
the available information within this short timeframe.
This is quite rare for experienced reviewers who
typically require only a few minutes per record. The
data to be extracted from each record can be entered
into a simple pro forma.

A typical primary care record is normally divided
into around five sections with each containing a range
of personal, demographic and clinical information on
the patient (Box 3). The reviewer should systematically
screen each individual section to identify (or
otherwise) the necessary evidence to answer the following
key questions:

Can triggers be detected?

If yes, detected triggers should prompt the reviewer to
examine the relevant section of the record in more
detail to determine if the patient came to any form of
harm. The majority of detected triggers will not be
linked to harm incidents. In some instances more than
one trigger may help to detect the same episode of
harm. Similarly, a single trigger may help to detect
more than one harm incident. If no trigger is detected,
or if 20 minutes has elapsed, the reviewer should
proceed to the next record and repeat the process for
the whole sample.

Did harm occur?

It may be necessary for the reviewer to examine other
sections of the record before deciding whether a harm
incident has occurred. If evidence of harm is detected,
the reviewer should consider where it originated and
its severity level and should judge perceived preventability.
If no harm is detected, the reviewer should
continue reviewing the record (returning to the first
question) or commence with the next record if applicable.
When reviewers are uncertain whether harm
occurred they should not record the incident.

What was the severity of the harm
detected?

The reviewer should grade the severity of every incidence
of detected harm using the classification system
which is most commonly applied (Box 4).[20] This
system has some potential limitations. Code ‘G’ (‘permanent
patient harm’) may only become apparent in
the months after the review and codes ‘H’ and ‘I’ will
be very rare in primary care and are unlikely to go
undetected. Arguably, other methods may be better
suited to analysing and learning from these incidents.

Was the detected harm incident
preventable?

The reviewer should make a decision on whether the
detected harm was preventable, which is based on a
combination of the evidence found in the medical
record and their own professional judgement at that
time. If a more in-depth analysis is required to support
or refute a judgement it should be undertaken after the
review, as discussed in Stage 3 below.

Where did the harm incident originate?

As before, the reviewer should arrive at an initial decision
based on the recorded evidence and their professional
judgement. The circumstances leading to the eventual
harm event may have originated in primary or secondary
care, or a combination of both.

Stage 3 Reflection and action

Once the sample of records has been reviewed, clinicians
or teams may want to reflect on their findings
and consider a number of potential actions, including
making immediate improvements to patient care. Based
on the trigger tool pilot study and follow-up feasibility
work with front-line primary care teams,15 we describe
below a number of possible actions that can be taken
in terms of immediate improvements and in relation
to the identification of patient safety learning needs.

Action at the patient and EPR level

The quality of information in individual electronic
patient records can be improved through updating, correcting or clarifying them in real time, which may
also act as a defence mechanism in terms of
minimising further risk to the patients. For example:

flan adverse drug reaction to codeine is detected, but
has not been entered as a clinical Read code. The
clinician enters the appropriate Read code to help
prevent prescription of this item in the future.

fla harm incident was detected where a patient had
to be hospitalised after falling and sustaining a large
laceration. The clinician identifies drug-induced
postural hypotension as a likely contributing factor.
She recalls a telephone discussion with a relative
who expressed concern about the patient’s ability
to manage at home which had not been documented
at the time. She takes a few minutes to
retrospectively update the record.

• The clinician finds a positive trigger – ‘repeat
medication item discontinued’ – but there is no
reason for this change documented during the
consultation. She discusses her finding with her
colleague who made the entry. He clarifies the
record by retrospectively adding his rationale for
stopping the medication.

fla harm incident is detected where a patient’s
estimated glomerular filtration rate (eGFR) is rapidly
declining. The clinician advises the patient to
discontinue the anti-inflammatory drugs that she
has been regularly using and to attend the surgery
for regular monitoring. The patient’s eGFR improves
to her normal baseline over the following
weeks. In this case an opportunity to resolve a harm
incident or minimise its severity and complications
through immediate action is demonstrated.

• It may be necessary to acknowledge and disclose
errors to patients and apologise for harm that may
have occurred. For example, a clinician detects the
trigger ‘AST/ALT (aspartate aminotransferase/alanine
aminotransferase) >150’. The result is surprising
as she recently reviewed the patient and
concluded that he was clinically well. On further
investigation she discovers that an error had occurred
when identity labels were attached to the
specimen. The labels of two patients with similar
names were accidentally ‘switched’ during a routine
phlebotomy session. She informs both patients
of the error, apologises on behalf of the practice
team and sends further specimens.

Detected triggers may also help to prevent a patient
suffering specific incidents of unnecessary harm in the
future. For example:

• The clinician detects a positive trigger ‘INR >5’ in
the record of an elderly patient with mild dementia.
There is no recorded evidence of harm, but she
holds a family conference where it is agreed that
future INR results will be phoned to the daughter.
She also agrees with the family and pharmacist to
issue other medications in a Dosette Box.

• While scanning the medical record for the trigger
‘Hb<10’, a clinician discovers that an elderly patient
on warfarin has not had her haemoglobin checked
for at least five years. She discusses this with the
practice nurse who adds this test during the patient’s
next phlebotomy appointment.

• Detecting specific contextual information in a
single record which is strongly indicative of preventable
harm (but where no harm incident occurred),
may act as a red flag which points to other
patients in the group under review facing increased
clinical risk. For example, detecting (and resolving)
an incident involving a patient being inappropriately
co-prescribed warfarin and aspirin led to a wider
audit which uncovered two other similar cases. The
practice took immediate corrective action for the
patients concerned and to help prevent future
harm from this specific safety threat.

• The detection of some harm incidents may have
much wider implications within the practice. For
example, a small number of preventable harm
incidents related to non-steroidal anti-inflammatory
drug (NSAID) prescribing were detected in
patients with heart failure. However, the practice
team decided to audit care for elderly patients and
those prescribed warfarin or a proton pump inhibitor
(PPI) to establish the full extent of these
issues. They also develop practical prescribing
guidelines for the team.

Action by the individual practitioner

Evidence suggests that a majority of clinicians remain
unaware of the scale and nature of the patient safety
problem.[21–24] Amongst those with some level of awareness
there is a tendency to believe that the problem is
‘somewhere else’, rather than in their own practice.[25]
A difficult task for many will be shifting attitudes and
behaviours in terms of acknowledging that avoidable
harm occurs locally, accepting that screening for it
should be a priority and indicating a willingness to
minimise future clinical risk.

The following examples are also possible outcomes
and actions of trigger tool review, which motivated
practitioners may have to consider:

• On detection of a preventable harm incident,
practitioners should consider whether they have
sufficient contextual evidence to plan and implement
necessary improvement. They may need
to explore cases in depth by reviewing the records
again in more detail and at greater length. If there is
still a lack of understanding as to why a harm
incident occurred, the clinician should undertake
a significant event analysis (SEA).[26]

• Individual practitioners may also reflect on
whether the review process and findings have any
other personal and professional implications. For
example, an incident of harm is detected where an
inappropriately high dosage of an antipsychotic
drug caused increasing confusion, falls and injury
to a patient in a nursing home. The clinician might
recognise a learning need to improve her knowledge
of patients with dementia and problematic
behavioural symptoms. As a result she might attend a
workshop dealing with this subject presented by a
local psychiatrist.

flat an individual level, writing up a short report
of the review process and outcomes – including
personal reflections and efforts to improve safety –
which could then be used as a basis for discussion
during annual appraisal as well as evidence for
claiming CPD credits.

Action by the practice team

Many of the practice team’s potential actions can be
agreed during team meetings. Different forums may
be used, including dedicated SEA meetings, or protected
learning time (PLT) sessions. Some of the
actions the practice team may consider are discussed
below:

• Identifying and addressing local learning needs.
For example, a reviewer may detect a case where
an elderly patient’s INR temporarily increases to >5
after prescription of an oral antibiotic for a suspected
urinary tract infection. The learning point
which is shared with clinicians during a practice meeting is that anti-coagulation patients require
more intensive monitoring when suffering episodes
of comorbidity.

• The practice designs and implements a specific
improvement task as a consequence of a trigger
tool review which indicates that the care of a
specific at-risk patient group should be prioritised.
They decide to use plan–do–study–act (PDSA)
cycles27 as a rapid method to audit and improve
INR monitoring in housebound patients and enhance
communication systems between practice
and community based staff.

• Many practices will lack the time and resources
to fully consider the implications of, and respond
effectively to, every detected harm incidentwhich is
judged to be preventable. This implies that some
incidents will have to be prioritised over others.

Action at the primary–secondary care
interface level

fla patient safety incident28 has been detected that
should be officially notified to the local primary
care organisation or the national patient safety
agency using existing incident reporting systems.
For example, a specific batch of influenza vaccines
is implicated in a greater than expected number of
adverse reactions. The practice’s report allows the
local authority to recall the batch and prevent any
further adverse reactions.

• In selected cases it may be necessary to inform
secondary care of harm incidents which originated
in their setting. For example, a practice detects four
incidents of post-operative, superficial cellulitis in
patients undergoing gynaecological procedures.
The practice nurse and GP notice that absorbable
sutures have been used externally in every case. The
senior partner writes to the relevant clinical directors
to make them aware of the incidents.

• The practice team may wish to share their practical
experience and outcomes of improvement initiatives
with other surgeries. For example, a practice
successfully implements a new system to monitor
and manage patients prescribed warfarin. The
practice shares its learning with its partners in a
local improvement programme.

Conclusion

We have described a potentially feasible process for
screening electronic records to detect episodes of
preventable harm to patients in UK primary care
settings. Further research evidence of the utility of
this approach is necessary, particularly with regard to
its professional acceptability and pragmatic feasibility, including resolving statistical issues over the measurement
of harm rates in populations and subpopulations
of patients.

However, we would suggest that if patient safety is
really a national priority then decision makers should
be directing efforts to explicitly identifying and minimising
preventable harm. Clearly some may view the
mass introduction of the trigger tool as a further
opportunity cost in an already squeezed contractual
environment. In contrast we suggest that as aminimum
the trigger tool approach should not be perceived as an
added extra, but should actually be mandated by
policy makers as the basis around which existing
safety-related learning and improvement efforts are
concentrated and directed. For example, explicit policy
attempts to address serious safety issues are presently
focused around expectations that GPs and their teams
participate in and provide evidence of activities such
as clinical audit, incident reporting and significant
event analysis. Evidence for the effectiveness of these
strategies in addressing and improving patient safety
concerns in primary care is either limited or lacking.
[29–31] Additionally, there is a lack of direction given
to primary care teams on how to identify safety-related
concerns. The findings from the application of the
trigger tool suggest that most harm events identified in
this way would have remained unknown utilising the
conventional methods outlined, or were ignored for
reasons unknown.

At a minimum we would suggest that policy makers
start to take an interest in the potential for screening
EPRs for avoidable harm as a means to direct more
meaningful safety-related learning and improvement.
The patient safety components of the general medical
services contract (through a local enhanced service)
and GP appraisal (to direct learning) could both act as
conduits in facilitating the rapid introduction of this
method as one means of addressing preventable harm
in primary care.

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McKay J, Bowie P and Lough M. Variations in the ability of general medical practitioners in applyingtwo methods of clinical audit: a five-year study of assessment by Peer Review. Journal of Evaluation in Clinical Practice 2006;12:622–9.